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PSUR WRITING MANUAL


At SJ Pharma Consulting, LLC in Mendham, NJ, we provide our clients with a 100-page manual that has detailed instructions concerning how to prepare an E2C-compliant PSUR. The manual includes the steps that are required to extract supporting data from the safety database.

Table of Contents

1.0 List of Tables
6

2.0 List of Figures
7

3.0 References
8

4.0 Definitions, Acronyms, and Abbreviations
8

5.0 PSUR Overview
13
5.1 Introduction 13
5.2Scope of Information13
5.3 Purpose of PSURS14
5.4 Product Authorization14

6.0 Frequency of Review and Reporting15
6.1 Regular and Ad Hoc Submission of Periodic Safety Update Reports15
6.2 PSURS – Other Countries16
7.0 PSUR Preparation17
7.1
PSUR Process Workflow
17
7.2
Matrix of Job Roles and Responsibilities
18
7.3
Table of Symbols Used in ARISg
19
8.0 Periodic Safety Update Report (PSUR) – Format20
8.1Executive Summary20
8.2 Introduction20
8.2.1 World Wide Market Authorization Status20
8.3 Update of Regulatory Authority or MAH Actions Taken for Safety Reasons21
8.4 Changes to Reference Safety Information21
8.5 Patient Exposure22
8.6 Presentation of Individual Case Histories22
8.7 Cases Presented in the Line Listings22
8.8 Presentation of the Line Listings23
8.9 Summary Tabulations24
8.10 Cumulative Listing of Serious Adverse Drug Reactions24
8.11 Market Authorization Holder(s)25
8.12 Studies25
8.13 Newly Analyzed Company Sponsored Studies25
8.14 Targeted New Safety Studies25
8.15 Other Information25
8.15.1 Efficacy Related Information25
8.15.2 Late-Breaking Information25
8.15.3 Risk Management Plan25
8.15.4 Risk-Benefit Analysis Report26
8.16 Overall Safety Evaluation26
8.17 Conclusion26
9.0 Running the PSUR26
9.1 Safety Systems Aggregate PSUR Line Listings and Summary Tables27
9.2 Generating the PSUR Line Listing Tabulations27
9.2.1 ARISg Admin Module Selection28
10.0 General Information38
11.0 Medically Confirmed, Spontaneous, and Authority, Non-Serious/Listed Adverse Events38
12.0 Medically Unconfirmed, Spontaneous, and Authority Adverse Events41
13.0 Cumulative Listing44
14.0 Batch Updating Procedures47
14.1Saving and Naming Procedures for PSUR Batch Updating Files49
14.2 Saving and Naming Procedures for Selected AER Files50
15.0 Run-Time Parameters51
16.0 Attachments (Appendices)68
16.1Appendix 1: Scheduling Procedure Document69
17.0 Appendix 2: Pharmacovigilance Aggregate Reports Definitions79
17.1Appendix 3: PSUR QC Check List82
17.2 Appendix 4: PSUR Template86
18.0 Description of the Drug89
19.0 Global Registration and Marketing Status90
20.0 Changes to Reference Safety Information91
21.0 Estimated Drug Exposure92
22.0 Presentation of Individual Cases94
23.0 Individual Case History Analysis95
24.0 Initial Reports98
25.0 Follow-Up Reports Containing New Medically Significant Information98
26.0 Medical Assessment98